Philips Achieva 3.0TX PET-MRI Patient Support Table Installation Defect
Philips is recalling the Achieva 3.0TX PET-MRI system because the patient support table floor plate may be incorrectly installed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for structural installation defect with no reported illnesses or injuries. The identified hazard is theoretical rather than established, warranting score 3 per the rubric.
Plain-English summary
Philips North America LLC is recalling the Achieva 3.0TX for PET, Magnetic Resonance System. The patient support table floor plate may be incorrectly installed on affected units.
The system has been distributed worldwide, including throughout the United States and in over 140 countries. The FDA has classified this as a Class II recall.
Healthcare facilities and medical professionals using this equipment should contact Philips North America LLC or the FDA for information regarding this recall and any recommended actions.
The recalled product
- Product
- Achieva 3.0TX for PET, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 781479
- UDI-DI n/a
- Serial No. 43102.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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